NCT02614027|Completed
Prevalence of Lipodystrophy Syndrome and Its Role as Cause of Metabolic Disturbances
METALIP
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METALIP
Sponsor study identifier
Secondary identifiers
OTHER · Ethics Committee
observational
276
1 country
1
Study Start
February 2016
Actual (reported)Primary Completion
February 2018
Actual (reported)Study Completion
June 2018
Actual (reported)To evaluate the prevalence of lipodystrophy syndrome in patients receiving currently available antiretroviral drugs, and the prevalence of associated metabolic syndrome in HIV-infected patients with a previous diagnosis of lipodystrophy syndrome, according to the severity of fat accumulation and antiretroviral drug use.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 21, 2015
Actual (reported)November 25, 2015
Actual (reported)February 2016
Actual (reported)February 2018
Actual (reported)June 2018
Actual (reported)Prevalence of metabolic syndrome as defined by the NCEP-ATP III (National Cholesterol Education Programme-Adult Treatment Panel III)
Prevalence of the different components of this syndrome: Abdominal obesity: waist circumference ≥102 cm in men and ≥88 cm in women, hypertriglyceridemia: ≥150 mg/dl (1.695 mmol/l), low HDL-C: \<40 mg/dl in men and \<50 mg/dl in women, high blood pressure (BP): \>130/85 mmHg, and high fasting glucose: \>110 mg/dl.
3 months
Prevalence of lipodystrophy syndrome as defined by changes in fat by DXA
Comparison of changes in visceral and subcutaneous fat during current antiretroviral therapy for patients receiving current antiretroviral regimens and who never received thymidine analogues, didanosine, lopinavir, indinavir, or nelfinavir.
6 meses
Value of dual X-ray absorptiometry (DXA) in predicting the development of lipodystrophy and metabolic syndrome
3 months
Evaluation and analytical determinations of the different components of the syndrome
Comparison of changes in fat (visceral and subcutaneous) by dual X-ray absorptiometry since therapy initiation
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
HIV-infected patients on antiretroviral therapy with current drugs (excluding drugs previously associated with fat disturbance), and HIV-infected patients with previous evaluation of lipodystrophy syndrome in different severity, as determined by DXA and questionnaire.
Ramon y Cajal Hospital
Madrid, 28034, Spain
Jose L Casado, MD
Ramon y Cajal Hospital
276 participants (actual enrollment reported by the registry).
First Submitted
November 21, 2015
First Posted
November 25, 2015
Study Start
February 2016
Actual (reported)Effect of Metabolaid® on AMPK Activation for Weight Loss
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Primary Completion
February 2018
Actual (reported)Study Completion
June 2018
Actual (reported)Last Updated
July 2, 2018
Record last verified: 2018-06
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Source: ClinicalTrials.gov.
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